Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Squamous Cell Carcinoma
- Sponsor
- Second Xiangya Hospital of Central South University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Development of computer algorithm to identify pCR features
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.
Detailed Description
This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with lung squamous cell carcinoma receiving neoadjuvant chemoimmunotherapy (ranging 2 to 4 cycles) will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for whole exon sequencing (WES) testing, and personalized detection panel will be customized based on WES testing results. Peripheral blood will be collected 1 day before each cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery, and 3 weeks after surgery for ctDNA testing. In addition, the prediction model of AI-based pathology will be constructed by AI deep learning based on pathological sections of pre-treatment biopsy tissues. All inclued patients will be regularly followed up for at least 5 years.
Investigators
Liu Wenliang
Professor
Second Xiangya Hospital of Central South University
Eligibility Criteria
Inclusion Criteria
- •Histopathology or cytology confirmed the lung squamous cell carcinoma
- •Age ranging from 18 to 75
- •Agree to participate in this study and sign an informed consent form
- •Treatment-naive tumor
- •According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor
- •Sufficient tissue/blood samples are available to meet research requirements
- •The ECOG PS score is 0-1
Exclusion Criteria
- •Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
- •Non-squamous NSCLC
- •Unresectable IIIa-IIIb tumor
- •Patients with solid organ or blood system transplantation
- •Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors
- •Patients with interstitial lung disease
- •Patients with acute or chronic infectious disease
- •Pregnant and lactating women
- •Patients who have undergone other clinical drug trials
Outcomes
Primary Outcomes
Development of computer algorithm to identify pCR features
Time Frame: From retrospective data collection to algorithm development (6 month)
Development of computer algorithm to identify pCR features
ctDNA resolution
Time Frame: Up to 2 years
ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathologic complete response (pCR)
Pathologic completet response (pCR) rate
Time Frame: Up to 1 year
pCR rate is defined as the percentage of participants having an absence of residual tumor cells in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Validation of computer algorithm to identify pCR features
Time Frame: From prospective data collection to algorithm validation (6 months)
Validation of computer algorithm to identify pCR features
Secondary Outcomes
- Major pathological response (MPR) rate(Up to 1 year)
- Perioperative pain evaluation(Up to 3 years)
- Health-related Quality of Life(Up to 5 years)
- Objective response rate(ORR)(Up to 1 year)
- Adverse events (AEs)(Up to 5 years)
- Perioperative complications rate(Up to 3 years)
- Disease free survival (DFS)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)